Study Of Neoantigen MRNA Vaccines In Patients With Resectable Pancreatic Cancer

Study Overview

Study of Neoantigen mRNA Vaccines in Patients With Resectable Pancreatic Cancer

The purpose of this study is to evaluate the safety and efficacy of treating pancreatic cancer with surgery to remove cancerour tissue, followed by camrelizumab and a personalized cancer mRNA vaccines.

The first purpose of this study is to evaluate the safety of treating pancreatic cancer with surgery to remove cancerour tissue. Following with camrelizumab and a personalized Neoantigen mRNA Vaccines, and then with chemotherapy.

Pancreatic Cancer

PROCEDURE: Surgery
DRUG: Camrelizumab
BIOLOGICAL: SJ-Neo006
DRUG: Gemcitabine+Abraxane

2024NZKY-014-02

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-03-11	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-03-17
First Submitted that Met QC Criteria 2024-03-17	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-03-22
First Posted (ACTUAL) 2024-03-22	Results First Posted N/A	Last Verified 2024-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Pancreatic Cancer Resectable primary pancreatic tumor	PROCEDURE: Surgery Tumors of patients with pancreatic cancer must be radiographically resectable, and subjects with histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1) will be selected for neoantigen vaccine cre DRUG: Camrelizumab Camrelizumab will be administered 6 weeks post-tumor resection. BIOLOGICAL: SJ-Neo006 SJ-Neo006 will be prepared as personalized tumor Vaccines and administered 9 weeks post-tumor resection (+/- 2 weeks). DRUG: Gemcitabine+Abraxane Gemcitabine+Abraxane regimen will be administered 21 weeks post-tumor resection.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Pancreatic Cancer

Resectable primary pancreatic tumor

PROCEDURE: Surgery

Tumors of patients with pancreatic cancer must be radiographically resectable, and subjects with histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1) will be selected for neoantigen vaccine cre

DRUG: Camrelizumab

Camrelizumab will be administered 6 weeks post-tumor resection.

BIOLOGICAL: SJ-Neo006

SJ-Neo006 will be prepared as personalized tumor Vaccines and administered 9 weeks post-tumor resection (+/- 2 weeks).

DRUG: Gemcitabine+Abraxane

Gemcitabine+Abraxane regimen will be administered 21 weeks post-tumor resection.

Primary Outcome Measures	Measure Description	Time Frame
Incidence of Treatment Emergent Adverse Events (TEAEs)	To observe and evaluate the safety of Neoantigen mRNA vaccine combined with Camrelizumab, for the number of participants with treatment-related adverse events as assessed by CTCAE v5.0.	2 years

Secondary Outcome Measures	Measure Description	Time Frame
Disease control rate (DCR)	The efficacy of Neoantigen mRNA vaccine combined with Camrelizumab by tumor lesion recurrence cycle at different time.	3,6,12 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Xinbo Wang, MD

Phone Number: 13505172912

Email: wxinbo2008@163.com

Study Contact Backup

Name: Sizhen Wang, MD

Phone Number: 15195900565

Email: wsizhen@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Subjects voluntarily participate in this clinical study and sign the Informed Consent Form (ICF).
Subjects must be >/= 18 years of age at time of informed consent.
Subjective with radiographically resectable primary pancreatic tumors with radiographic features consistent with adenocarcinoma will be evaluated for surgical resection.
Subjects with histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1) will be selected for neoantigen vaccine creation.
Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG).
Subjects must not have had prior chemotherapy, radiation therapy, or immunotherapy for Pancreatic ductal adenocarcinoma（PDAC）.
Subjects with estimated survival > 12 weeks.

Prior neoadjuvant treatment, radiation therapy, anti-PD-1 antibody or any other immune therapy for pancreatic ductal adenocarcinoma.
Known hypersensitivity or allergy to the active substance or to any of the excipients of SJ-neo006, Camrelizumab, Gemcitabine, Abraxane.
Actie, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment.
Known infection with hepatitis B or C, or history of human immunodeficiency virus (HIV) infection or subjects receiving immunosuppressive or myelosuppressive medications that would, in the opinion of the investigator, increase the risk of serious neutropenic complications.
Pregnancy, breastfeeding, or intending to become pregnant during the study or within 90 days after the last dose of study treatment.
New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysthythmia, or electrocardiogram abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder.
History or autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease.
Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Jiangsu Synthgene Biotechnology Co.Ltd.

Investigators

STUDY_DIRECTOR: Xinbo Wang, MD, Jinling Hospital, China

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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